J+PRAS YOUNG'S Thread
FDA 510(k) clearance K143413 · decided 2015-09-11
Clearance details
- K-number
- K143413
- Device name
- J+PRAS YOUNG'S Thread
- Applicant
- Y. Jacobs Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2014-11-28
- Decision date
- 2015-09-11
- Days to decision
- 287 days
- Clearance type
- Traditional
- Product code
- NEW
- Device class
- 2
- Regulation number
- 878.4840
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Seoul, KR
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.